Drug Holiday for HIV Kids Can be Done Safely

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These studies were published as abstracts and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Children treated as infants for HIV appear to be able to have antiretrovirals safely stopped until medically necessary to restart.

Note when antiretrovirals were started for the first time later in the course of disease, treatment interruption was not as successful.

SEATTLE -- It's safe to interrupt HIV treatment for children, but only if they were placed on initial therapy before the virus could damage their immune systems.

That's the implication of two studies of treatment interruption with very different outcomes, presented here at the annual Conference on Retroviruses and Opportunistic Infections.

One study, presented by Mark Cotton, MD, PhD, of Stellenbosch University in Tygerberg, South Africa, gave the final results of the long-running CHER trial. The primary finding of CHER was that treating infants as soon as they are diagnosed -- often within a few weeks of birth -- offers better outcomes than waiting until they show signs of a failing immune system.

A second question posed by the researchers was whether treatment can safely be stopped for any reason after it is started, Cotton told reporters.

The trial included 375 infants who were randomly assigned to deferred treatment or to therapy for either 40 or 96 weeks, after which it would be stopped until starting again became medically necessary.

The researchers previously reported that the time to death or failure of the first-line antiretroviral regimen was significantly shorter in the children who had therapy deferred.

But, after a median of 4.8 years of follow-up, Cotton reported, the two treatment interruption arms showed no difference in the time to death or failure of the first-line antiretroviral regimen.

At the end of the trial, he reported:

26% of those who stopped therapy after 40 weeks remained off medication, compared with 33% in the 96-week arm. The difference was not significant.

There were 55 hospital admissions among the 143 children in the 40-week arm and 56 among the 143 in the 96-week arm.

There was a trend to fewer grade three and four clinical events in the 96-week arm.

The bottom line, Cotton told MedPage Today, is that after early treatment, an interruption appears safe. But, he cautioned, "it's not ready for implementation into treatment guidelines yet."

"But if you have to stop for other reasons, you can," he said.

The other study also looked at treatment interruption but in a very different patient population, according to Dalton Wamalwa, MBChB, of the University of Nairobi, in Kenya.

The researchers enrolled 121 infants who started antiretroviral therapy within the first 13 months of life, at a median of five months, and followed them for two years of therapy, he reported.

Of those who completed at least two years of treatment, 42 were eligible to be randomly assigned to continue treatment for another 18 months or to stop until their CD4 cell proportion fell below 25%.

The interruption appeared safe, Wamalwa reported, with no significant differences in growth patterns or morbidity.

But in the interruption arm, 18 of the 21 children had to restart therapy, 14 of them within three months of stopping. For that reason, the trial's data safety monitoring board stopped the study last year because there were too few participants remaining.

The finding -- especially compared with the South African study -- "highlights what a difference a few weeks makes for infants with HIV," Wamalwa told MedPage Today.

In his study, 40% of the participants had advanced HIV disease by the time they were first placed on therapy, which may have meant their immune systems were already so damaged they could not sustain the later interruption.

The two studies define the window that will allow later treatment interruption, according to Elaine Abrams, MD, of Columbia University in New York City, who chaired a press conference at which the details were presented.

The Kenyan study showed that "if your kids are sick by the time you start them on therapy, it doesn't make sense to stop," she told MedPage Today.

On the other hand, "when you start very early, before they're sick, [later treatment interruption] at least appears feasible for a period of time," she said.

Such treatment interruption might be desirable to reduce exposure to the toxicity of some drugs or to cut down on a family's financial burden, Abrams said.

The South African study had support from the NIH, the Perinatal HIV Research Unit, CIPRA-SA, and KID CRU.

The Kenyan study had support from the NIH and the University of Washington.

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